FDA.reportPublic FDA data

Tramadol Hydrochloride

Product NDC
63629-4900
11-digit product format
636294900
Labeler code
63629
Product ID
63629-4900_23c1d136-5e61-4a00-abcd-9043aca0fed3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tramadol Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
NDA022370
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2015-07-01
Marketing end
0000-00-00
Substance
TRAMADOL HYDROCHLORIDE
Active strength
150 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-4900-1EA - Each63629-490027c704d2-3074-480a-a974-4e0c38301fc412015-10-02
63629-4900-2EA - Each63629-490067ef6ac0-5781-46c5-8d63-7bf3ecd654c512015-10-02
63629-4900-3EA - Each63629-4900a0a41b9f-32c2-46df-b5b5-831968f0e13d12015-10-02
63629-4900-4EA - Each63629-4900d21becf9-41ca-427b-9d99-a635c4ea66d712015-10-02
63629-4900-5EA - Each63629-4900e3b62b38-9b1a-42eb-a1dc-ceea212656fa12015-10-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-4900-06362949000015 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63629-4900-0) 2015-09-110000-00-00NoNoCurrent